J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025

On June 1, 2025 J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, reported interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 (ASCO 2025), the world’s largest oncology conference, held in Chicago, USA (Press release, J INTS BIO, JUN 1, 2025, View Source [SID1234653563]).

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JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented.

‘Confirmed’ clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy

One of the key findings of the ASCO (Free ASCO Whitepaper) presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity.

In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases.

Safety confirmed up to 300 mg, with therapeutic signals in brain metastases

No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug’s excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months.

In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue.

JIN-A02 gains national spotlight as government grants accelerate development

In addition to the ASCO (Free ASCO Whitepaper) announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the ‘2025 Baby Unicorn Fostering Project’ by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The ‘Baby Unicorn Fostering Project’ is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as ‘potential unicorns’. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential.

With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments.

Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA.

"The ASCO (Free ASCO Whitepaper) presentation of JIN-A02’s ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government’s continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization"

First site activation in Australia for PD1-Vaxx Neo-POLEM Phase II trial

On June 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first site activation within Australia, as part of the investigator sponsored Phase II Neo-POLEM clinical trial (Press release, Imugene, JUN 2, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0af44840-0a27-5641-dade-e0642353307d/1st_Australian_site_activated_PD1_Vaxx_Neo_POLEM_Ph_II_trial.pdf [SID1234653561]).

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Neo-POLEM is a Phase II study investigating the potential of PD1-Vaxx, a neoadjuvant PD-1 vaccine, to improve treatment outcomes for patients with mismatch repair-deficient / microsatellite instability high (dMMR/MSI-high) colorectal cancer. Approximately 15% of patients with colorectal cancer have the dMMR/MSI-high subtype.

The trial is an IST being conducted by Cancer Research UK Southampton Clinical Trials Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group (AGITG).

The primary objective of the study is to determine major pathological response rates, a measure of tumour size reduction post-treatment with PD1-Vaxx before surgery, with secondary objectives to assess the safety of PD1-Vaxx, evaluate biomarkers, and evaluate the objective response rates and overall survival.

This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population. The trial will recruit patients in both Australia and the United Kingdom.

Imugene’s CEO and Managing Director Leslie Chong said: "We’re very pleased to see this Neo-POLEM IST open and enrolling in Australia. PD1-Vaxx has the potential to offer a durable immune response and improve treatment outcomes, and we look forward to further progress in both Australia and the UK."

Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of more than 1.2 million cases and a mortality rate of approximately 50%. About 80% of patients with colon cancer have localised and resectable disease at diagnosis. Approximately 15% of CRC is dMMR/MSI-high.

Transgene and NEC Present Durable Disease-Free Survival and Sustained T Cell Responses at 24 Months with Individualized Cancer Vaccine TG4050

On June 1, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported to have presented new positive data on TG4050 in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Transgene, JUN 1, 2025, View Source [SID1234653559]).

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These positive data confirm that individualized neoantigen therapeutic vaccine TG4050 is safe and feasible in the adjuvant setting of resectable HPV-negative locally advanced head and neck squamous cell carcinoma (HNSCC). TG4050 induces, as monotherapy, long-lasting immune responses to vaccine neoantigens sustained for up to 2 years, and these results met all trial endpoints (NCT04183166) including safety, feasibility, immune activation and disease-free survival (defined as survival without recurrence or death for any cause).

TG4050 is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.

Positive data from Phase I, confirming proof of principle
of Transgene’s viral vector based individualized cancer vaccine TG4050
in HPV-negative locally advanced head and neck cancer

100% disease free survival at a minimum of 2-year follow-up of treated patients (median follow-up: 30 months) in the Phase I part of the trial: all patients in the TG4050 treatment arm remain disease free while 3 patients in the observational arm have relapsed.
Persistence of neoantigen-specific CD8+ T cell responses over 2 years after the start of TG4050 has been observed.
Dr. Alessandro Riva, CEO of Transgene, commented: "The sustained clinical and immunogenicity outcomes observed over two years of TG4050 monotherapy, along with the positive safety profile, mark an important milestone for Transgene. These results reinforce both the clinical promise of TG4050 and our commitment to accelerate the development of this individualized immunotherapy in adjuvant setting for patients with HPV-negative, locally advanced head and neck cancer."

Motoo Nishihara, Corporate EVP, and CTO, at NEC, commented: "This positive readout, combined with the durability of the efficacy data at two years, underscore the clinical potential of individualized cancer vaccine programs. It is a strong validation of our innovative AI platform and our dedication to advancing solutions that deliver meaningful, long-term value to patients and healthcare systems alike."

Ongoing Phase II part of Phase I/II clinical trial of individualized neoantigen therapeutic cancer vaccine TG4050

TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on the promising data obtained in the Phase I part of the trial, Transgene and NEC extended the joint development of TG4050 in this indication with a Phase II extension of the trial.

The Phase II part of the trial, aimed at confirming the encouraging results in a larger patient population and evaluating both immunological and clinical outcomes, is currently underway. All patients are expected to be randomized by Q4 2025. Altogether, the Phase I/II study will comprise approximately 80 patients.

Dr Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology), will discuss the data presented at ASCO (Free ASCO Whitepaper) 2025, the unmet medical need and current treatment landscape for patients suffering from head and neck cancers in a live virtual event taking place on June 6, 2025 (9:00 p.m. ET; 3:00 p.m. CET).

Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis

On June 1, 2025 Novartis reported data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali (ribociclib) plus endocrine therapy (ET, a non-steroidal aromatase inhibitor) in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence across age and menopausal status (Press release, Novartis, JUN 1, 2025, View Source [SID1234653558]). The data will be presented today at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Results at median follow-up of 44.2 months show that patients receiving Kisqali continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status1. In this one-year post-treatment analysis, pre-menopausal and younger patients, who often present with more aggressive disease characteristics, experienced greater reductions in risk of recurrence and fewer treatment discontinuations due to adverse events (AEs) than post-menopausal patients1.

"As the incidence of early onset breast cancer increases, it is encouraging to see that ribociclib continues to deliver durable risk reduction for a broad population of patients with EBC, including younger patients," said Dr. Kevin Kalinsky, Division Director of Medical Oncology and Director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University. "Coupled with the lower rates of discontinuation due to AEs seen in this subgroup, these data reinforce the benefit of three-year adjuvant treatment with ribociclib as a well-tolerated intervention for patients seeking to reduce the likelihood of their cancer coming back."

Pre-menopausal patients
(n = 2238) Post-menopausal patients
(n = 2844)
Hazard ratioa
(95% CI) All
Kisqali = 1115
ET = 1123 All
Kisqali = 1424
ET = 1420
Invasive disease-free survival
(iDFS) 0.671
(0.518-0.870) 0.746
(0.607-0.917)
Distant disease-free survival
(DDFS) 0.655
(0.498-0.861) 0.759
(0.612-0.941)
Recurrence-free survival
(RFS) 0.641
(0.486-0.845) 0.735
(0.588-0.919)
Disposition in Kisqali arm, n (%)
Discontinuation due to AE 179 (16.1) 326 (22.9)
Dose reduction due to AE 248 (22.4) 332 (23.6)
a Hazard ratios between treatment arms (RIB + NSAI; NSAI alone), stratified by stage, prior chemotherapy, and geographic region.

Addressing Recurrence in Other At-Risk Groups
A separate real-world analysis of EBC patients who met the NATALEE trial eligibility criteria and received ET monotherapy found that Black patients were more likely to be younger, pre-menopausal, have stage III tumors, and have more extensive nodal involvement than white patients. After adjusting for these factors, Black patients also had worse RFS, DDFS, and overall survival than their white counterparts. These findings reinforce the critical need to improve care for Black patients with the addition of a CDK4/6 inhibitor to their adjuvant treatment3.

Novartis is continuing to add to the body of evidence on the efficacy and safety of Kisqali in different patient populations. Trial design details will be presented at ASCO (Free ASCO Whitepaper) for the Adjuvant WIDER study, which is enrolling patients that closely reflect the population seen in clinical practice, including more patients from racial and ethnic minority groups4.

"There is an undeniable and urgent need to improve outcomes for vulnerable patient populations, including younger and Black patients, who often face more aggressive forms of breast cancer and remain at high risk of recurrence," said Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer, Novartis US. "With Kisqali, we have the opportunity to reduce the risk of recurrence for these patients with early breast cancer, while we continue to offer significant survival benefit to patients living with metastatic disease."

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO5,6. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable5,6. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria5,6. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial5,6.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in 99 countries worldwide, including the U.S. FDA and the European Commission7,8. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET7. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression8. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist7,8.

In EBC, ribociclib (Kisqali) is the only CDK4/6 inhibitor recommended by the NCCN Guidelines for breast cancer for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 39. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration10. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials11-21. The NCCN Guidelines also recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI9, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC22; and has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer23. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line24.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com

Imfinzi regimen reduced risk of progression, recurrence or death by 29% in early-stage gastric cancer vs. chemotherapy alone in MATTERHORN Phase III trial

On June 1, 2025 AstraZeneca reported positive results from the MATTERHORN Phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) versus chemotherapy alone (Press release, AstraZeneca, JUN 1, 2025, View Source [SID1234653555]). Patients were treated with neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

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These results will be presented today during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (abstract #LBA5) and simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an EFS hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen.

For the secondary endpoint of overall survival (OS), a strong trend was observed in favour of the Imfinzi-based perioperative regimen (HR=0.78; 95% CI 0.62-0.97; p=0.025). The trial will continue to follow OS, which will be formally assessed at the final analysis.

Yelena Y. Janjigian, MD, Chief Attending Physician of the Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering Cancer Center, New York, and principal investigator for the trial, said: "Despite receiving curative-intent surgery and chemotherapy, patients with gastric and gastroesophageal cancers frequently develop recurrent disease. Results from the MATTERHORN trial showed that more than two-thirds of patients treated with a durvalumab-based perioperative regimen had not experienced a recurrence or were progression-free after two years. This new treatment approach should become the new standard of care in this setting based on these results."

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "This immunotherapy-based perioperative regimen has the potential to change the clinical paradigm in early gastric and gastroesophageal junction cancers based on the reduction in risk of progression, recurrence or death by nearly a third and the strong trend towards improved survival. As the third positive trial of perioperative treatment with Imfinzi across multiple tumour types, the MATTERHORN trial further validates this approach and highlights our commitment to bringing novel therapies to early stages of disease where there is the greatest chance for cure."

Summary of results: MATTERHORN


Imfinzi-based regimen

(n=474)

Chemotherapy regimen

(n=474)

EFSi

Median EFS (95% CI) (in months)

NR (40.7-NR)

32.8 (27.9-NR)

HR (95% CI)

0.71

(0.58-0.86)

p-valueii

p<0.001

EFS rate at 12 months (%)

78.2

74.0

EFS rate at 24 months (%)

67.4

58.5

OS

mOS (in months)

NR

47.2

HR (95% CI)

0.78

(0.62-0.97)

p-valueiii

p=0.025

i. EFS rates are based on Kaplan Meier estimates.

ii. Threshold to declare statistical significance p-value<0.0239.

iii. Threshold to declare statistical significance p-value<0.0001.

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.1 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.1 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.2 In 2024, there were approximately 43,000 drug-treated patients in the US, European Union (EU) and Japan with early-stage and locally advanced gastric or GEJ cancer.3 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.4

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.5

Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy. Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and one in four patients do not survive beyond two years, reflecting high unmet medical need.6-7 Additionally, the five-year survival rate remains poor, with less than half of patients alive at five years.8

MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by Imfinzi or placebo every four weeks for up to 12 cycles after surgery (including two cycles of Imfinzi or placebo plus FLOT chemotherapy and 10 additional cycles of Imfinzi or placebo monotherapy).

In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomization until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pCR rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia.

Imfinzi
Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Imfinzi is approved in the US and other countries as a perioperative treatment in combination with neoadjuvant chemotherapy for muscle-invasive bladder cancer based on the NIAGARA Phase III trial. Additionally, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.

Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.